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DESTINY-Breast03: PFS and ORR Subgroup Analysis (May 21, 2021 DCO Date) 

PFS Subgroup Data

PFS Subgroup Data11. Cortés J, Im SA, Iwata H, et al. Subgroup analysis by disease history and prior treatments of patients with HER2-positive metastatic breast cancer from DESTINY-Breast03, a randomized phase 3 study of trastuzumab deruxtecan vs trastuzumab emtansine [poster and abstract]. Poster presented at: European Society for Medical Oncology (ESMO) Virtual Congress 2022; September 9-13, 2022. Ann Oncol. 2022;33(suppl 7). Abs 236P.

  • In a sensitivity analysis among the 35 early progressors (disease progression within 6 months after [neo]adjuvant therapy or 12 months for pertuzumab-containing regimens) in the recurrent metastatic BC subgroup (15 treated with T-DXd and 20 treated with T-DM1), PFS was consistent with the overall primary analysis (HR, 0.19; 95% CI, 0.05-0.71); however, this is based on a small sample size11. Cortés J, Im SA, Iwata H, et al. Subgroup analysis by disease history and prior treatments of patients with HER2-positive metastatic breast cancer from DESTINY-Breast03, a randomized phase 3 study of trastuzumab deruxtecan vs trastuzumab emtansine [poster and abstract]. Poster presented at: European Society for Medical Oncology (ESMO) Virtual Congress 2022; September 9-13, 2022. Ann Oncol. 2022;33(suppl 7). Abs 236P.
  • A PFS benefit for T-DXd versus T-DM1 was observed in all subgroups11. Cortés J, Im SA, Iwata H, et al. Subgroup analysis by disease history and prior treatments of patients with HER2-positive metastatic breast cancer from DESTINY-Breast03, a randomized phase 3 study of trastuzumab deruxtecan vs trastuzumab emtansine [poster and abstract]. Poster presented at: European Society for Medical Oncology (ESMO) Virtual Congress 2022; September 9-13, 2022. Ann Oncol. 2022;33(suppl 7). Abs 236P.

PFS in Key Subgroups.11. Cortés J, Im SA, Iwata H, et al. Subgroup analysis by disease history and prior treatments of patients with HER2-positive metastatic breast cancer from DESTINY-Breast03, a randomized phase 3 study of trastuzumab deruxtecan vs trastuzumab emtansine [poster and abstract]. Poster presented at: European Society for Medical Oncology (ESMO) Virtual Congress 2022; September 9-13, 2022. Ann Oncol. 2022;33(suppl 7). Abs 236P.

PFS in Key Subgroups.11. Cortés J, Im SA, Iwata H, et al. Subgroup analysis by disease history and prior treatments of patients with HER2-positive metastatic breast cancer from DESTINY-Breast03, a randomized phase 3 study of trastuzumab deruxtecan vs trastuzumab emtansine [poster and abstract]. Poster presented at: European Society for Medical Oncology (ESMO) Virtual Congress 2022; September 9-13, 2022. Ann Oncol. 2022;33(suppl 7). Abs 236P.

<p>PFS in Key Subgroups.<span class="tooltip"><span class="tooltip-text"><sup>1</sup></span><span class="tooltip-content" style="display: none;"><span>1. Cortés J, Im SA, Iwata H, et al. Subgroup analysis by disease history and prior treatments of patients with HER2-positive metastatic breast cancer from DESTINY-Breast03, a randomized phase 3 study of trastuzumab deruxtecan vs trastuzumab emtansine [poster and abstract]. Poster presented at: European Society for Medical Oncology (ESMO) Virtual Congress 2022; September 9-13, 2022. <em>Ann Oncol</em>. 2022;33(suppl 7). Abs 236P.</span></span></span></p>

Note: Number of events are shown as the number of patients with the event (n)/ the total number of patients in the subgroup (N)

aPatients who had rapid progression (ie, progression that occurred within 6 months after receipt of neoadjuvant or adjuvant therapy or within 12 months after receipt of a neoadjuvant or adjuvant pertuzumab-containing regimen) were considered to have had 1 line of previous therapy. Lines of previous therapy did not include endocrine therapy; bPatients with any reported history of BM described by Cortés et al. in N Engl J Med 2022; cPatients with clinically stable BM observed during the baseline scan described by Hurvitz et al. 2021 at SABCS 2021; dAmong patients with 1 line of therapy in the metastatic setting excluding hormone therapy.

PFS According to Prior Pertuzumab Use.11. Cortés J, Im SA, Iwata H, et al. Subgroup analysis by disease history and prior treatments of patients with HER2-positive metastatic breast cancer from DESTINY-Breast03, a randomized phase 3 study of trastuzumab deruxtecan vs trastuzumab emtansine [poster and abstract]. Poster presented at: European Society for Medical Oncology (ESMO) Virtual Congress 2022; September 9-13, 2022. Ann Oncol. 2022;33(suppl 7). Abs 236P.

PFS According to Prior Pertuzumab Use.11. Cortés J, Im SA, Iwata H, et al. Subgroup analysis by disease history and prior treatments of patients with HER2-positive metastatic breast cancer from DESTINY-Breast03, a randomized phase 3 study of trastuzumab deruxtecan vs trastuzumab emtansine [poster and abstract]. Poster presented at: European Society for Medical Oncology (ESMO) Virtual Congress 2022; September 9-13, 2022. Ann Oncol. 2022;33(suppl 7). Abs 236P.

<p>PFS According to Prior Pertuzumab Use.<span class="tooltip"><span class="tooltip-text"><sup>1</sup></span><span class="tooltip-content" style="display: none;"><span>1. Cortés J, Im SA, Iwata H, et al. Subgroup analysis by disease history and prior treatments of patients with HER2-positive metastatic breast cancer from DESTINY-Breast03, a randomized phase 3 study of trastuzumab deruxtecan vs trastuzumab emtansine [poster and abstract]. Poster presented at: European Society for Medical Oncology (ESMO) Virtual Congress 2022; September 9-13, 2022. <em>Ann Oncol</em>. 2022;33(suppl 7). Abs 236P.</span></span></span></p>

PFS According to Presence of Visceral Disease at Baseline.11. Cortés J, Im SA, Iwata H, et al. Subgroup analysis by disease history and prior treatments of patients with HER2-positive metastatic breast cancer from DESTINY-Breast03, a randomized phase 3 study of trastuzumab deruxtecan vs trastuzumab emtansine [poster and abstract]. Poster presented at: European Society for Medical Oncology (ESMO) Virtual Congress 2022; September 9-13, 2022. Ann Oncol. 2022;33(suppl 7). Abs 236P.

PFS According to Presence of Visceral Disease at Baseline.11. Cortés J, Im SA, Iwata H, et al. Subgroup analysis by disease history and prior treatments of patients with HER2-positive metastatic breast cancer from DESTINY-Breast03, a randomized phase 3 study of trastuzumab deruxtecan vs trastuzumab emtansine [poster and abstract]. Poster presented at: European Society for Medical Oncology (ESMO) Virtual Congress 2022; September 9-13, 2022. Ann Oncol. 2022;33(suppl 7). Abs 236P.

<p>PFS According to Presence of Visceral Disease at Baseline.<span class="tooltip"><span class="tooltip-text"><sup>1</sup></span><span class="tooltip-content" style="display: none;"><span>1. Cortés J, Im SA, Iwata H, et al. Subgroup analysis by disease history and prior treatments of patients with HER2-positive metastatic breast cancer from DESTINY-Breast03, a randomized phase 3 study of trastuzumab deruxtecan vs trastuzumab emtansine [poster and abstract]. Poster presented at: European Society for Medical Oncology (ESMO) Virtual Congress 2022; September 9-13, 2022. <em>Ann Oncol</em>. 2022;33(suppl 7). Abs 236P.</span></span></span></p>

ORR Subgroup Data

ORR Subgroup Data1-31. Cortés J, Im SA, Iwata H, et al. Subgroup analysis by disease history and prior treatments of patients with HER2-positive metastatic breast cancer from DESTINY-Breast03, a randomized phase 3 study of trastuzumab deruxtecan vs trastuzumab emtansine [poster and abstract]. Poster presented at: European Society for Medical Oncology (ESMO) Virtual Congress 2022; September 9-13, 2022. Ann Oncol. 2022;33(suppl 7). Abs 236P.2. Im S-A, Xu B, Kim, S-B, et al. Trastuzumab deruxtecan vs T-DM1 in HER2+ mBC in Asian subgroup: Results of the randomized phase 3 study DESTINY-Breast03 [presentation]. Presented at: the Japanese Society of Medical Oncology Annual Meeting 2022; February 17-19, 2022. Presentation PS2-1.3. Hurvitz SA, Kim SB, Chung WP, et al. Trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with HER2+ metastatic breast cancer: subgroup analyses from the randomized phase 3 study DESTINY-Breast03 [presentation and abstract]. Presented at: San Antonio Breast Cancer Symposium (SABCS) 2021 Annual Meeting; December 7-10, 2021. Cancer Res. 2022;82(suppl 4). Abs GS3-01.

Confirmed ORR Across Patient Subgroups.1-31. Cortés J, Im SA, Iwata H, et al. Subgroup analysis by disease history and prior treatments of patients with HER2-positive metastatic breast cancer from DESTINY-Breast03, a randomized phase 3 study of trastuzumab deruxtecan vs trastuzumab emtansine [poster and abstract]. Poster presented at: European Society for Medical Oncology (ESMO) Virtual Congress 2022; September 9-13, 2022. Ann Oncol. 2022;33(suppl 7). Abs 236P.2. Im S-A, Xu B, Kim, S-B, et al. Trastuzumab deruxtecan vs T-DM1 in HER2+ mBC in Asian subgroup: Results of the randomized phase 3 study DESTINY-Breast03 [presentation]. Presented at: the Japanese Society of Medical Oncology Annual Meeting 2022; February 17-19, 2022. Presentation PS2-1.3. Hurvitz SA, Kim SB, Chung WP, et al. Trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with HER2+ metastatic breast cancer: subgroup analyses from the randomized phase 3 study DESTINY-Breast03 [presentation and abstract]. Presented at: San Antonio Breast Cancer Symposium (SABCS) 2021 Annual Meeting; December 7-10, 2021. Cancer Res. 2022;82(suppl 4). Abs GS3-01.

Confirmed ORR Across Patient Subgroups.1-31. Cortés J, Im SA, Iwata H, et al. Subgroup analysis by disease history and prior treatments of patients with HER2-positive metastatic breast cancer from DESTINY-Breast03, a randomized phase 3 study of trastuzumab deruxtecan vs trastuzumab emtansine [poster and abstract]. Poster presented at: European Society for Medical Oncology (ESMO) Virtual Congress 2022; September 9-13, 2022. Ann Oncol. 2022;33(suppl 7). Abs 236P.2. Im S-A, Xu B, Kim, S-B, et al. Trastuzumab deruxtecan vs T-DM1 in HER2+ mBC in Asian subgroup: Results of the randomized phase 3 study DESTINY-Breast03 [presentation]. Presented at: the Japanese Society of Medical Oncology Annual Meeting 2022; February 17-19, 2022. Presentation PS2-1.3. Hurvitz SA, Kim SB, Chung WP, et al. Trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with HER2+ metastatic breast cancer: subgroup analyses from the randomized phase 3 study DESTINY-Breast03 [presentation and abstract]. Presented at: San Antonio Breast Cancer Symposium (SABCS) 2021 Annual Meeting; December 7-10, 2021. Cancer Res. 2022;82(suppl 4). Abs GS3-01.

<p>Confirmed ORR Across Patient Subgroups.<span class="tooltip"><span class="tooltip-text"><sup>1-3</sup></span><span class="tooltip-content" style="display: none;"><span>1. Cortés J, Im SA, Iwata H, et al. Subgroup analysis by disease history and prior treatments of patients with HER2-positive metastatic breast cancer from DESTINY-Breast03, a randomized phase 3 study of trastuzumab deruxtecan vs trastuzumab emtansine [poster and abstract]. Poster presented at: European Society for Medical Oncology (ESMO) Virtual Congress 2022; September 9-13, 2022. <em>Ann Oncol</em>. 2022;33(suppl 7). Abs 236P.</span><span>2. Im S-A, Xu B, Kim, S-B, et al. Trastuzumab deruxtecan vs T-DM1 in HER2+ mBC in Asian subgroup: Results of the randomized phase 3 study DESTINY-Breast03 [presentation]. Presented at: the Japanese Society of Medical Oncology Annual Meeting 2022; February 17-19, 2022. Presentation PS2-1.</span><span>3. Hurvitz SA, Kim SB, Chung WP, et al. Trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with HER2+ metastatic breast cancer: subgroup analyses from the randomized phase 3 study DESTINY-Breast03 [presentation and abstract]. Presented at: San Antonio Breast Cancer Symposium (SABCS) 2021 Annual Meeting; December 7-10, 2021. <em>Cancer Res</em>. 2022;82(suppl 4). Abs GS3-01.</span></span></span></p>

aNumber of patients with event (n)/total number of patients in group (N); bPatients with rapid progression on (neo)adjuvant therapy were included. Line of therapy does not include endocrine therapy; cAsian countries include Republic of Korea, Japan, China, Taiwan, and Hong Kong.

Abbreviations

BC = breast cancer

;

BM = brain metastases

;

CR = complete response

;

DCO = data cut-off

;

HER2 = human epidermal growth factor receptor 2

;

HR = hazard ratio

;

NE = not evaluable

;

mBC = metastatic breast cancer

;

mo = month

;

ORR = objective response rate

;

PFS = progression-free survival 

;

PR = partial response

;

T-DXd = trastuzumab deruxtecan

;

T-DM1 = trastuzumab emtansine

References

1. Cortés J, Im SA, Iwata H, et al. Subgroup analysis by disease history and prior treatments of patients with HER2-positive metastatic breast cancer from DESTINY-Breast03, a randomized phase 3 study of trastuzumab deruxtecan vs trastuzumab emtansine [poster and abstract]. Poster presented at: European Society for Medical Oncology (ESMO) Virtual Congress 2022; September 9-13, 2022. Ann Oncol. 2022;33(suppl 7). Abs 236P.

2. Im S-A, Xu B, Kim, S-B, et al. Trastuzumab deruxtecan vs T-DM1 in HER2+ mBC in Asian subgroup: Results of the randomized phase 3 study DESTINY-Breast03 [presentation]. Presented at: the Japanese Society of Medical Oncology Annual Meeting 2022; February 17-19, 2022. Presentation PS2-1.

3. Hurvitz SA, Kim SB, Chung WP, et al. Trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with HER2+ metastatic breast cancer: subgroup analyses from the randomized phase 3 study DESTINY-Breast03 [presentation and abstract]. Presented at: San Antonio Breast Cancer Symposium (SABCS) 2021 Annual Meeting; December 7-10, 2021. Cancer Res. 2022;82(suppl 4). Abs GS3-01.

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